Catheter coupler and methods of exchanging catheters
The present disclosure relates to a catheter coupler and methods of exchanging catheters within a patient with a replacement catheter. The catheter coupler is configured to couple to a first catheter that has been disposed within a patient and coupled to a second or replacement catheter. Once the coupler is coupled to the first and second catheter, the first catheter may be withdrawn from the patient, which simultaneously advances the second or replacement catheter into the previous position of the first catheter. The coupler may include a body with a first end and a second end. The coupler may have a plurality of barbs disposed on both ends of the body of the coupler, wherein the barbs are configured to couple the coupler to the lumen of the catheters.
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This application claims priority to U.S. Provisional Application No. 62/722,419, filed on Aug. 24, 2018, and titled “Catheter Coupler and Methods of Exchanging Catheters,” which is hereby incorporated by reference in its entirety.
TECHNICAL FIELDThe present disclosure relates generally to drainage catheters for medical use. More specifically, the present disclosure relates to a looped drainage catheter and methods of exchanging drainage catheters.
The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. While various aspects of the embodiments are presented in drawings, the drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:
The various embodiments disclosed herein generally relate to, but are not limited to, drainage catheters and related methods of use. More specifically, the various embodiments relate to a drainage catheter that may be used for percutaneous nephrostomy or nephropyelostomy, including providing temporary drainage for an obstructed renal collecting system. In some instances, the obstructed area may become infected, and antibiotics may have limited efficacy reaching the kidney if the obstruction is not drained. Percutaneous nephrostomy may be used to alleviate the obstruction and to create a route for antibiotic instillation and/or other treatments, if needed. As explained in further detail below, in some embodiments, the disclosed drainage catheter may be sufficiently pliable to minimize potential injury during insertion, but also sufficiently rigid to maintain a generally U-shape bend when deployed within the kidney, which may tend to avoid clogging and promote drainage. Also disclosed herein are methods for inserting the drainage catheter into a patient's kidney and methods of exchanging drainage catheters. The specific examples included herein are presented by way of example, the present disclosure may be applied to other catheter applications.
Various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. Many of these features may be used alone and/or in combination with one another.
Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. The components of the present disclosure, as generally described and illustrated in the drawings herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus is not intended to limit the scope of the disclosure, but is merely representative of possible embodiments of the disclosure. In some cases, well-known structures, materials, or operations are not shown or described in detail. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
The phrases “connected to,” “coupled to,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.
The terms “distal” and “proximal” refer to opposite ends of a medical device, including the coupler disclosed herein, as well as the exemplary catheters. As used herein, the distal portion of the catheter is the portion that first enters the patient's body during insertion, while the proximal portion is a portion at the opposite end, along the longitudinal direction of the catheter.
The term “resilient” refers to a component, device, or object having a particular shape that can then be elastically deformed into a different shape, but that may return to the original shape when unconstrained. For example, a resilient portion of the catheter may have a first shape when unconstrained (i.e., when no exterior force acts upon the catheter) and, in use, the resilient portion may then be constrained (i.e., temporarily engaged with a guidewire) to elastically deform the resilient element into a second shape (i.e., a straightened condition over the guidewire). After the catheter is disposed in the kidney, the guidewire may be removed and the catheter may return to its first shape (unconstrained) or substantially to its first shape.
While the written description and figures may reference use of the catheter for percutaneous nephrostomy, the catheter may be used for providing drainage to other organs or anatomical structures, as well as for infusion of medication. Accordingly, the particular uses of the catheter outlined herein are meant as examples and not meant to limit use of the catheter and/or the coupler disclosed herein, to nephrostomy or kidney placement.
With reference to
To facilitate and accurate placement of the catheter 100 within the kidney 200, the distal and proximal tube segments 105, 110 may each include various depth markers 140, 145, 150, 155 printed thereon at predetermined points along the catheter 100. In some embodiments, the depth markers 140, 145, 150, 155 encircle the circumference of the respective tube segments 105, 110. For example, with reference to
With reference to
The inner surface 160 of the arcuate end portion 115 may comprise a plurality of holes 175 formed thereon. The holes 175 may extend through the inner surface 160 of the catheter 100 such that they are in communication with the lumen 120. The holes 175 may thus be configured to provide a pathway for waste or other fluids out of the kidney and antibiotics and other medical fluids into the kidney. The holes 175 disposed on the inner surface 160 of the catheter 100 may allow guidewire passage through the catheter 100 without the need of fluoroscopy. In some embodiments, the outer surface 165 of the catheter 100 is free of holes. This absence of holes may be configured to minimize potential blockage and clogging of the holes to maintain patency of the catheter 100 as the kidney tissues press against the catheter 100. In other words, the body of the catheter 100 may tend to prevent tissue from collapsing against the holes 175 disposed along the inner surface 160 due to the arcuate shape of the catheter 100, thus helping maintain patency and prevent clogging.
The arcuate end portion 115 of the catheter 100 may further comprise radiopaque marker bands 180, 185, and 190 printed thereon to facilitate placement of the arcuate end portion 115 of the catheter 100 f. For example, with reference to
In some embodiments, the catheter 100 may include a hydrophilic coating on the catheter surface. The hydrophilic coating may absorb and bind water to promote a smooth and slippery surface and help reduce pain, pressure, or discomfort during the insertion and removal process. With reference to
With particular reference to
As generally illustrated in
As noted previously, the arcuate end portion 115 may be resilient such that the arcuate end portion 115 rends to return to its initial curved configuration once the catheter 100 is free from external forces (see
With reference to
In some embodiments, a pigtail nephrostomy catheter may be inserted into a kidney 200 of the patient through the first calyx 222 to access the renal pelvis 225. The pigtail nephrostomy catheter may not need dual access to the kidney 200 like the drainage catheter 100 and therefore the pigtail catheter may not exit the kidney 200 through the second calyx 223. The pigtail nephrostomy catheter may be inserted for a short-term nephrostomy, however, if a longer-term nephrostomy catheter is needed, the pigtail catheter may be replaced using a long-term nephrostomy catheter, such as the drainage catheter 100. If the pigtail catheter is replaced, the drainage catheter 100 may pass through the pre-existing tract into the kidney 200 made by the pigtail catheter and a fresh tract may be created to access the second calyx 223 so that the drainage catheter 100 may exit the patient.
Once disposed, over time the catheter 100 may become unsuitable to the purpose of emplacement. For example, the holes 175 or the lumen 120 may become blocked, or the patient may respond adversely to the material of which the catheter 100 is manufactured, or another medical treatment may require replacement of the particular catheter 100 with a different catheter. Rather than withdraw the catheter 100 and repeat the initial emplacement procedure with a new catheter, in some procedures a coupler (such as 300 of
The coupler 300 may be configured to couple to a catheter by inserting a portion of the coupler 300 into a lumen of the catheter. For instance, the first diameter D1 of each barb 310, 330 may be sized smaller than a diameter of a lumen of a catheter to which the coupler 300 is configured to be coupled. The second diameter D2 may be larger than a diameter of a lumen of the catheter. For example, with reference to the catheter of
The coupler 400 may be used to facilitate replacement of the catheter 100 with the replacement catheter 100′. The coupler 400 may be coupled to the proximal tube segment 110 of the catheter 100 by inserting the first barb 410 of the coupler 400 in the lumen 120 of the proximal tube segment 110 of the catheter 100. The second barb 430 of the coupler 400 may be inserted into a lumen 120′ of a distal tube segment 105′ of the replacement catheter 100′. In some embodiments, if the distal tube segment 105′ of the replacement catheter 100′ includes a tapered lead-in portion, the lead-in portion may be removed (cut off) before inserting the coupler 400 into the lumen 120′. The coupler 400 may be coupled to either the catheter 100 or the replacement catheter 100′ first, then coupled to the other catheters 100, 100′.
A guidewire 230′ may be inserted into the lumens 120, 120′, 402 of the catheters 100, 100′ and the coupler 400. With the distal tube segment 105′ of the replacement catheter 100′ coupled via the coupler 400 to the proximal tube segment 110 of the catheter 100, the distal tube segment 105 of the catheter 100 may be drawn out of the patient. As the catheter 100 is drawn out of the patient, the replacement catheter 100′ is pulled through the first insertion site 215, through the renal pelvis 225, and through the second insertion site 245. Radiopaque marker bands 180′, 185′, 190′ disposed at an arcuate end portion 115′ of the replacement catheter 100′ may facilitate placement of the arcuate end portion 115′ in the renal pelvis 225. In
In the illustrated embodiments, the coupler handle 801 comprises a first handle 802, a second handle 804, a torsion spring 806, a first clamp jaw 808, a second clamp jaw 810, and a backstop 812. The first and second handles 802, 804 may be held in a spread configuration by the torsion spring 806. The torsion spring 806 may also press the first clamp jaw 808 and the second clamp jaw 810 toward or against each other. The coupler 500 may be seated between the first and second clamp jaws 808, 810 such that the coupler 500 buts against the backstop 812. The flange 504 may serve to prevent the coupler 500 from moving rearward toward the torsion spring 806 as pressure may be applied to couple the coupler 500 to the catheter 100, 100′. The backstop 812 may be configured with a pin (not shown) that may protrude into the lumen of the coupler 500. The backstop 812 may be configured with a recessed ring (not shown) in the face of the backstop 812 proximal to the first and second clamp jaws 808, 810. The pin and/or recessed ring may assist in keeping the coupler 500 stable as pressure is applied to couple the coupler 500 to the catheter 100, 100′.
In some embodiments, the coupler 500 does not have a backstop to prevent axial movement. Axial movement in this embodiment may be limited by the flange 504 and the barb 520 when the flange 504 or the barb 520 engage with the first and second clamp jaws 808, 810.
The first and second handles 802, 804 may be pressed toward each other in opposing directions FA, FA′, which may simultaneously cause the first and second clamp jaws 808, 810 to move in opposing directions FB, FB′ and thereby release the coupler 500 from the coupler handle 801. The coupler delivery system 800 may be provided fully assembled having the coupler 500 pre-coupled to the clamp-grip 801 from a manufacturer. In another embodiment, the coupler 500 may be coupled to the coupler handle 801 immediately prior to and preparatory to coupling the coupler 500 to the catheter 100, 100′.
The coupler handle 901 may a snap fitting 902 to secure the coupler 500 to the coupler delivery system 900. The snap fitting 902 comprises a plurality of arms 904, with each arm 904 having a lug 906. The lug 906 of each arm 904 may be configured to snap over the first distal barb 510 of the coupler 500 so as to couple the coupler 500 to the coupler handle 901. The snap fitting 902 may be sufficiently resilient to retain the coupler 500 on the coupler handle 901 against the application of lateral forces, and may also be sufficiently flexible to allow the snap fitting 902 to release the coupler 500 from the coupler handle 901 at the application of a predetermined lateral force. In other words, the amount of force to disengage the coupler handle 901 from the coupler 500 is less than the amount of force to remove the coupler 500 from the lumen of one of the catheters 100, 100′. The medical care giver may also squeeze the distal tube segment 105, 105′ of the catheter 100, 100′ where the catheter 100, 100′ is coupled to the coupler 500 to ensure the catheter 100, 100′ and the coupler 500 remain coupled together as lateral force is applied to the coupler handle 901 to release the coupler 500 from the coupler handle 901.
The coupler handle 901 may include a stabilizing pin 908 which fits into the lumen of the coupler 500 to provide stability while the coupler 500 is being coupled to the catheter 100, 100′. The coupler handle 901 may be manufactured of any material suitable to the coupling 500.
As noted above, the coupler handle 901 may include a plurality of the ribs 910 and the voids 912 to provide a gripping surface for the medical care giver. The gripping surface may be beneficial for medical care givers if their hands are wet or if the gloves they are wearing are wet. The coupler 500 may be coupled to the coupler handle 901 during manufacture. In another embodiment, the coupler 500 may be fitted to the coupler handle 901 immediately prior to and in preparation of the catheter replacement procedure.
A coupler delivery system according to any of the embodiments of this disclosure may be delivered to a medical care facility in the form of a sealed and sterile kit (not shown). By way of example without limitation, the kit may include the coupler delivery system, a guidewire, site preparation materials (such as, e.g., a cleaning swab), a shear, disposal materials, etc. The kit may include a replacement catheter (the coupler delivery system 1200 includes a catheter as a component of the coupler delivery system 1200). The kit may also include a connector. The kit may also include further components which may couple to the connector for a particular purpose. A kit may be provided with a coupler delivery system and additional components as may be specially ordered by the health care system.
References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially straight” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely straight configuration.
Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.
Similarly, the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.
The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the invention to its fullest extent. The claims and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having ordinary skill in the art, with the aid of the present disclosure that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Moreover, the order of the steps or actions of the methods disclosed herein may be changed by those skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order or use of specific steps or actions may be modified. The scope of the invention is therefore defined by the following claims and their equivalents.
Claims
1. A catheter exchange system, comprising:
- a second catheter comprising: a tubular body having a first end and a second end; and a lumen extending from the first end of the tubular body to the second end of the tubular body; and
- a coupler comprising: a body having a first end and a second end; and at least one barb disposed at the first end of the coupler and at least one barb disposed at the second end of the coupler, wherein the coupler is configured to couple to a first catheter and the second catheter by coupling the first end of the coupler to the first catheter and coupling the second end of the coupler to the second catheter, wherein the coupler is configured to use during catheter replacement procedure to replace the first catheter with the second catheter, wherein the first catheter is configured to currently be disposed in a patient, wherein the coupler has a central body portion that is disposed between the at least one barb disposed on the first end and the at least one barb disposed on the second end, wherein the central body portion is flexible and allows the central body portion to bend, and wherein the central body portion includes a plurality of flex slots disposed in the body of the coupler that partially extend circumferentially around the central body portion.
2. The catheter exchange system of claim 1, wherein the first end of the coupler is coupled to the first catheter by inserting the first end of the coupler into a lumen of the first catheter.
3. The catheter exchange system of claim 2, wherein the second end of the coupler is coupled to the second catheter by inserting the second end of the coupler into the lumen of the second catheter.
4. The catheter exchange system of claim 1, wherein the coupler further comprises at least two barbs at the first end and at least two barbs at the second end.
5. The catheter exchange system of claim 1, further comprising a coupler handle, wherein the coupler handle is configured to grip the coupler and enable a user to insert the coupler into one of a lumen of the first catheter and the lumen of the second catheter.
6. The catheter exchange system of claim 5, wherein the coupler handle disengages from the coupler with a force less than an amount of force to remove the coupler from the lumen of the catheter one of the lumen of the first catheter and the lumen of the second catheter.
7. The catheter exchange system of claim 5, wherein the coupler handle includes a plurality of arms that extend from the coupler handle to grip the barbs of the coupler, and
- wherein each arm includes a lug that engages with the barbs of the coupler forming a snap fit between the coupler handle and the coupler.
8. The catheter exchange system of claim 5, wherein the coupler handle includes a well that grips the coupler, and
- wherein the well includes a lug that engages with the barbs of the coupler forming a snap fit between the coupler handle and the coupler.
9. The catheter exchange system of claim 1, wherein the coupler is pre-coupled to the second catheter.
10. A method for exchanging a first catheter disposed within a patient with a second catheter, the method comprising:
- coupling a first end of a coupler to the first catheter;
- coupling a second end of the coupler to the second catheter, such that the first catheter is coupled to the second catheter via the coupler; and
- removing the first catheter from the patient and advancing the second catheter within the patient by displacing the first catheter, such that the displacement of the first catheter removes the first catheter from the patient and simultaneously advances the second catheter within the patient.
11. The method of claim 10, wherein coupling the first end of the coupler to the first catheter is accomplished by inserting the first end of the coupler into a lumen of the first catheter.
12. The method of claim 10, wherein coupling the second end of the coupler to the second catheter is accomplished by inserting the second end of the coupler into a lumen of the second catheter.
13. The method of claim 10, further comprising inserting a guidewire through the first catheter, the coupler, and the second catheter.
14. A catheter kit comprising:
- a second catheter that includes a lumen extending from a first end to a second end of the catheter; and
- a coupler that includes barbs disposed at least at a first end and a second end of the coupler,
- wherein the coupler is configured to couple to a first catheter previously disposed in a patient and the second catheter by coupling the first end of the coupler to the first catheter and coupling the second end of the coupler to the second catheter,
- wherein the coupler has a central body portion that is disposed between the at least one barb disposed on the first end and the at least one barb disposed on the second end, and
- wherein the central body portion is flexible and allows the central body portion to bend.
15. The catheter kit of claim 14, further comprising a coupler handle coupled to the coupler that is configured to be detached from the coupler with a predetermined amount of force.
16. The catheter kit of claim 14, wherein the coupler is pre-coupled to the catheter.
17. The catheter exchange system of claim 1, wherein the central body portion comprises a flange with a plurality of flex slots disposed on both sides of the flange.
5549554 | August 27, 1996 | Miraki |
20050192638 | September 1, 2005 | Gelfand |
20060284423 | December 21, 2006 | Katsuno et al. |
20070241119 | October 18, 2007 | Durkin et al. |
20080021415 | January 24, 2008 | Durkin |
20080125696 | May 29, 2008 | Callahan |
20090139529 | June 4, 2009 | Worley |
20100076410 | March 25, 2010 | Ring |
20100312227 | December 9, 2010 | House |
20150308598 | October 29, 2015 | Lewis et al. |
20160158523 | June 9, 2016 | Helm |
20180153552 | June 7, 2018 | King |
20190290896 | September 26, 2019 | Phillips |
2018085566 | May 2018 | WO |
- European Search Report dated May 2, 2022 for EP19852805.1.
Type: Grant
Filed: Aug 23, 2019
Date of Patent: Nov 15, 2022
Patent Publication Number: 20200061363
Assignee: Merit Medical Systems, Inc. (South Jordan, UT)
Inventors: Richard Lindsay (Belfast), Kirk Loren Foote (Cottonwood Heights, UT)
Primary Examiner: Tatyana Zalukaeva
Assistant Examiner: Nhu Q. Tran
Application Number: 16/549,574
International Classification: A61M 39/10 (20060101); A61M 27/00 (20060101);